Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children

University of Oslo (UIO)

Status: Unknown

Conditions: Eye Diseases

Treatments: Device: Edmon

Study type: Interventional

Funder types: Other

Identifiers

NCT04150432

Exhaled propofol Children

Details and patient eligibility

About

Children due for elective eye surgery in propofol based anesthesia will be kept at steady state propofol infusion for maintenance, ventilation via endotracheal tube. Exhaled propofol will be measured continously by Edmon (R) (BBraun) monitor and compared with arterial plasma samples of propofol, drawn 3-5 times during the procedure.

Full description

The primary objective of the study is to determine the correlation between simultaneous concentrations of propofol in plasma and expiratory air in children during general anesthesia.

Key secondary objectives include correlating plasma and exhaled measurements of propofol with electroencephalogram (BIS) values and computer estimated propofol concentrations in plasma and brain (TCI: target control infusion) Primary endpoint: Exhaled air and plasma concentration ratios of propofol during general anesthesia in children.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective eye surgey

Exclusion criteria

• known propofol hypersensitivity

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

propofol

Experimental group

Description:

propofol general anesthesia, exhaled measurement of propofol

Treatment:

Device: Edmon